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Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

3 dicembre 2017 aggiornato da: Masonic Cancer Center, University of Minnesota

Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.

Secondary

  • Determine the progression-free, disease-free, and overall survival of patients treated with this regimen.
  • Determine the pattern of failure in patients treated with this regimen.
  • Evaluate the quality of life of patients treated with this regimen.
  • Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life.

Tertiary

  • Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
  • Evaluate the quality of saliva by examining total protein concentrations.
  • Quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients.
  • Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
  • Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.

OUTLINE: This is a pilot study.

  • Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later.
  • Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks.
  • Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection.

Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia.

Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

4

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • Masonic Cancer Center at University of Minnesota

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the head and neck

    • Stage IVA or IVB disease

      • Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
  • Measurable or evaluable disease
  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
  • Bilirubin normal

  • Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:

    • AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal

Exclusion Criteria:

  • Salivary gland, sinus, or nasopharyngeal primary disease
  • Evidence of distant metastatic disease
  • Pregnant or nursing
  • Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
  • Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
  • Peripheral neuropathy ≥ grade 2
  • Hearing loss ≥ grade 2
  • Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
  • Poor nutritional status, in the opinion of the investigator
  • Active infection
  • Active ischemic heart disease
  • Myocardial infarction within the past 6 months
  • Prior radiotherapy above the clavicles
  • Prior chemotherapy
  • Prior surgery to the primary tumor except biopsy
  • Concurrent amifostine or other investigational agents

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
Biologico: filgrastim
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
Altri nomi:
  • G-CSF
  • Neupogen
Biologico: pegfilgrastim
If applicable on day 5, repeating every 3 weeks for 2 courses.
Altri nomi:
  • Neulasta, G-CSF
Droga: cisplatin
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
Altri nomi:
  • CDDP
  • cisplatino
  • Platinolo AQ
  • cis-diamminedichloridoplatinum
Droga: docetaxel
Intravenous over 1 hour on day 1.
Altri nomi:
  • Taxotere(R)
Droga: fluorouracil
Intravenous continuously on days 1-4.
Altri nomi:
  • 5-FU
  • 5-fluorouracile
  • Adrucile
Procedura: conventional surgery
As appropriate, neck dissection.
Altri nomi:
  • chirurgia
Radiazione: radiation therapy
60 Gy 5 days/week x 6 weeks with cisplatin
Altri nomi:
  • radiazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients With Feeding Tube Dependency
Lasso di tempo: at 12 months
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
at 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Days With Progression-free Survival
Lasso di tempo: Between date of registration to date of first treatment failure or death.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Between date of registration to date of first treatment failure or death.
Number of Days - Overall Survival
Lasso di tempo: Between date of registration to date of death.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Between date of registration to date of death.
Number of Days With Disease Free Survival
Lasso di tempo: From Date of Registration to Date of First Treatment Failure or Death
All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.
From Date of Registration to Date of First Treatment Failure or Death
Time to Treatment Failure
Lasso di tempo: Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.
Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
Swallowing Ability - Quality of Life Scores
Lasso di tempo: Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).
Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
Lasso di tempo: baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Masonic Cancer Center, University of Minnesota

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Frank G. Ondrey, MD, PhD, Masonic Cancer Center, University of Minnesota

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2006

Completamento primario (Effettivo)

1 aprile 2008

Completamento dello studio (Effettivo)

1 aprile 2008

Date di iscrizione allo studio

Primo inviato

13 luglio 2006

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2006

Primo Inserito (Stima)

14 luglio 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 dicembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 dicembre 2017

Ultimo verificato

1 dicembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2005LS012
  • UMN-0502M67486

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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